Clinical Supply Logistics Resources

81. Overcoming Cell Therapy Supply Chain Challenges 5/11/2021

    For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.

82. The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective 3/29/2021

    Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.

83. Inside A Gene Therapy Facility, Commercialization & Industrialization Project 3/10/2021

    An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases. 

84. Managing Complex Global Drug Distribution And Expiry 1/12/2021

    A global top-ten pharma company sponsored a complex, 8-year Phase III trial across 43 countries. As costs mounted and supplies waned, it realized the trial could be better managed if outsourced. 

85. Direct-To-Representative Sample Distribution Services 4/30/2019

    One particularly effective approach to promote prescription drug products is to have pharma sales reps ‘hand carry’ samples to the health care practitioners within their territories.

86. Controlling Preanalytical Variability In Biospecimen Collections 4/5/2019

    Large, well-designed population studies and the interrelationships they reveal are the backbone of public health and serve as a foundation for medical research. The health and lifestyle information of participants, collected via questionnaire and linked to their biospecimen samples, allow investigators to examine the intricate relationships between genetics, physiology, behavior, environment, and disease. This eBook is an introduction to some of the variables that must be considered when collecting biospecimens as part of a cohort study.

87. Thinking Outside Of The Freezer: DNA And RNA Storage 3/8/2019

    While ultra-low temperatures are the current state-of-the-art solution for biospecimen storage, ambient storage is an interesting option and could be superior in certain limited situations. For many types of samples, it’s possible that we will always have to use ultra-low temperatures for long-term storage. For other sample types, such as DNA and RNA, there are alternative solutions.  

88. Transporting Critical Bio-Materials 3/7/2019

    The best mode of transportation for moving your irreplaceable material from Point A to Point B may not be one you are familiar with. Learn the pros and cons of standard options vs. specialized transport services.

89. Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures 2/26/2019

    One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.

90. Scaling The Advanced Therapy Supply Chain 2/13/2019

    This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.